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510(k) Data Aggregation
K Number
K051436Device Name
PRE' VAGINAL LUBRICANT
Manufacturer
INGFERTLITY, LLC
Date Cleared
2006-10-13
(499 days)
Product Code
PEB
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
INGFERTLITY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions.
- As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.
Device Description
This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms.
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